Utility of serological VivaDiag IgM/IgG rapid test kits for COVID-19 screening, during disease progression and following recovery

Abstract

Objectives: This study evaluated VivaDiag IgM/IgG Rapid Test (VDtest) for covid-19 screening, during disease progression and following recovery. Methods: Prospectively, 969 patients RT-PCR positive for SARS-CoV-2 virus were compared to VDtest in 166 individuals upon airport arrival; 62 active inpatient COVID-19 cases ranging 2-23 days; 741 recovered COVID-19 patients from diagnosis date (median 24-days). Findings: Screening; VDtest assay sensitivity 7.6% (95% CI 2.8-15.8%), specificity 94.3% (95% CI 87.1-98.1%). Active disease patients, positive IgG rate 27.4% and IgM positivity 0 of 62 patients. Recovery phase patients: positive rates of IgM and IgG were 0.7% and 1.2%, respectively, within 14-days of diagnosis date, increasing to 25.9% and 43.4%, respectively 14-days after diagnosis. Novelty: VDtest kit showed poor sensitivity and identification of COVID-19 infection for screening, moreover, need for larger sample study to confirm our findings.